Sevelamer Kern Pharma 2.4 g powder for oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sevelamer Kern Pharma 2.4 g oral suspension powder

Sevelamer carbonate

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sevelamer Kern Pharma is and what it is used for
2. What you need to know before taking Sevelamer Kern Pharma
3. How to take Sevelamer Kern Pharma
4. Possible adverse effects
5. How to store Sevelamer Kern Pharma
6. Package contents and other information

1. What Sevelamer KernPharma is and what it is used for

Sevelamer KernPharma contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract, thereby reducing serum phosphate levels in the blood.

Sevelamer is used to control hyperphosphataemia (high blood phosphate levels) in:

• adult patients on dialysis (a blood-cleansing technique). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);

• patients with chronic kidney disease (long-term) who are not on dialysis and have a serum (blood) phosphate level equal to or above 1.78 mmol/l.

Sevelamer should be used together with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.

Elevated serum phosphate levels may lead to hard deposits in the body called calcifications. These deposits may harden in blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphate may also cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before starting Sevelamer Kern Pharma

Do not take Sevelamer Kern Pharma

• if you have low levels of phosphate in the blood (your doctor will check this for you)

• if you have intestinal obstruction

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before taking sevelamer if you are in any of the following situations:

• difficulty swallowing

• problems with stomach or intestinal motility (movement)

• frequent vomiting

• active inflammation of the intestine

• you have undergone major stomach or intestinal surgery

• if you have severe inflammatory bowel disease.

Children and adolescents

The safety and efficacy have not been studied in children (under 18 years of age). Therefore, the use of sevelamer is not recommended in children.

Additional treatments:

Due to your kidney condition or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since sevelamer does not contain calcium, your doctor may prescribe additional calcium tablets.

• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood vitamin D levels and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor may monitor these levels and prescribe vitamin supplements as needed.

Special note for patients on peritoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by careful use of sterile techniques during bag exchanges. You must inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, tenderness or rigidity of the abdomen, constipation, fever, chills, nausea, or vomiting.

You should also expect to have closer monitoring if you have problems with low levels of vitamins A, D, E, K, and folic acid.

Taking Sevelamer Kern Pharma with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Sevelamer should not be administered at the same time as ciprofloxacin (an antibiotic).

• If you are taking other medicines for heart rhythm disorders or epilepsy, you must consult your doctor when taking sevelamer.

• The effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by sevelamer. Your doctor will advise you if you are taking these medicines.

• A deficiency of thyroid hormone may rarely occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and sevelamer. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) blood levels more closely.

• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking sevelamer.

Your doctor will regularly check for interactions between sevelamer and other medicines.

In some cases, sevelamer should be taken at the same time as another medicine. Your doctor may instruct you to take this medicine 1 hour before or 3 hours after taking sevelamer, or may consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. It is unknown whether sevelamer has any effect on the fetus.

Inform your doctor if you intend to breastfeed. It is unknown whether sevelamer passes into breast milk and could affect the baby.

Driving and using machines

It is unlikely that sevelamer affects your ability to drive or use machines.

3. How to take Sevelamer KernPharma

Sevelamer should be taken as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

The 2.4 g dose of oral suspension powder per sachet must be dispersed in 60 ml of water. It should be consumed within 30 minutes of preparation. It is important to drink all of the liquid, and it may be necessary to rinse the glass with water and drink that as well to ensure the entire dose has been ingested.

The recommended initial dose of sevelamer is 2.4–4.8 g per day, divided equally into three doses with meals. Your doctor will determine the exact initial dose and dosing regimen.

Initially, your doctor will monitor your blood phosphorus levels every 2–4 weeks and may adjust the dose of sevelamer as needed to achieve an appropriate phosphorus level.

Patients taking sevelamer should follow the diet prescribed for them.

If you take more Sevelamer KernPharma than you should

In case of a possible overdose, you must contact your doctor immediately.

If you forget to take Sevelamer KernPharma

If you forget to take a dose, skip it. Take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Since constipation could be an early symptom of intestinal obstruction, inform your doctor or pharmacist.

The following adverse effects have been reported in patients taking sevelamer:

Very common (may affect more than 1 in 10 patients):

vomiting, constipation, upper abdominal pain, nausea

Common (may affect up to 1 in 10 patients):

diarrhea, abdominal pain, indigestion, flatulence

Very rare (may affect up to 1 in 10,000 patients):

hypersensitivity

Frequency not known (cannot be estimated from available data):

cases of itching, rash, slow intestinal motility (movement), intestinal obstruction (signs include: severe distension, abdominal pain, bloating or cramps, severe constipation), intestinal wall perforation (signs include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen), gastrointestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Sevelamer KernPharma Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

The reconstituted suspension must be administered within 30 minutes after reconstitution.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer KernPharma

• The active substance is sevelamer carbonate. Each sachet of Sevelamer Kern Pharma contains 2.4 g of sevelamer carbonate, as indicated on the sachet.
• The other components are microcrystalline cellulose, sodium carboxymethylcellulose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

Appearance of the medicine and contents of the pack

Sevelamer Kern Pharma is a white to yellowish powder supplied in heat-sealed aluminium sachets. The aluminium sachets are packed in an outer carton.

Pack sizes:

90 sachets per box

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Synthon Hispania S.L.

C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat,

08830 Barcelona

Spain

or

Synthon s.r.o.

Microweg 22

6545 CM Nijmegen

The Netherlands

Date of the most recent revision of this leaflet: October 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/